BEUDAMED
    FDA Adverse Event Other Summary report: N

    NARKOMED

    MDR report key: 724569 · Received June 9, 2006

    Report

    Report Number
    2517967-2006-00046
    Event Type
    Other
    Date Received
    June 9, 2006
    Date of Event
    May 11, 2006
    Report Date
    May 12, 2006
    Manufacturer
    DRAEGER MEDICAL, INC.
    Product Code
    BSZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA

    Narratives

    Additional Manufacturer Narrative · 1

    H.3. A DRAGERSERVICE REPRESENTATIVE PERFORMED AN EVALUATION OF THE DEVICE. VISUAL INSPECTION AND PERFORMANCE TESTING FOUND THE MACHINE TO BE PERFORMING WITHIN ITS SPECIFICATIONS. THE DEVICE LOG WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION OF THE DEVICE LOG ON THE DATE OF OCCURRENCE INDICATED THAT THE DEVICE WAS OPERATING NORMALLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT; THE FIRST CASE OF THE DAY. THE PROCEDURE, A RIGHT TYMPANOPLASTY, WAS FOR A MALE PATIENT, 58 YEARS OF AGE, 179 POUNDS. DURING THE CASE, THE USER REPORTED THAT THEY WERE ABLE TO MANUALLY VENTILATE THE PATIENT AND THEN WENT INTO AUTOMATIC VENTILATION MODE. THE USER REPORTED THAT THE PATIENT CODED AND A THIRD PARTY MONITOR (PHILLIP'S) WAS IN USE AND INDICATED THE PATIENT WAS HAVING AN ARRHYTHMIA. THE CUSTOMER REPORTED THAT NO ALARMS WERE PRESENT FROM THE ANESTHESIA MACHINE. THE CASE WAS CANCELLED AND THE PATIENT IS CURRENTLY COMATOSE AND IS ON A CRITICAL CARE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NARKOMED ANESTHESIA MACHINE BSZ DRAEGER MEDICAL, INC. 6000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other